Topical composition and treatment

ABSTRACT

Methods and compositions for the topical treatment of burns, bedsores and other skin afflications are disclosed which comprise the topical application to affected areas of the skin of a composition comprising an aqueous mixture of calcium hydroxide and a fixed drying oil.

This invention relates to novel compositions for the treatment of burns,bedsores and other skin afflictions. More particularly, this inventionrelates to novel compositions for the topical treatment of skin lesionscaused by the application of pressure, heat or fire to the skin and to areduction in scarring of the skin as a result of such lesions.

Decubitus ulcer, more commonly known as bedsore; pressure sore ortrophic ulcer, is the ischemic necrosis and ulceration of skin tissueoverlying a bony prominence of the body that has been subjected toprolonged pressure against an object such as a cushion, mattress, cast,splint, etc.

The condition is most frequently found in patients who have beenbedridden for long periods of time such as the aged or infirmed andparticularly among those with severely diminished or totally absentsensation, such as those suffering from debilitation, emaciation orparalysis induced by physical injury or neurologic disorder.

Tissues over the sacrovertebral area, the pelvic area, the lower pelvicand thigh area, as well as the ankles, heels and elbows are especiallysusceptible to development of decubitus ulcers but other sites may alsobe involved depending upon the positions of the particular patient.

In its most serious presentations, decubitus ulcer may also effectmuscle and bone as well as the epidermis and dermis. These more seriousdecubitus ulcers require surgical removal and skin grafting for closure.

The best treatment for bedsores is prevention, i.e., frequent changingof the bedridden patients position and providing even distribution ofthe patient's weight. The latter may be accomplished through the use ofan anti-bed-sore mattress or cushion such as disclosed in French PatentNo. 2,598,910; U.S. Pat. Nos. 4,653,130; 4,517,693; 4,610,253 and FrenchPatent No. 2,471,185.

Burns to which the topical formulations of the present invention may beapplied are burns of the first degree, those which show redness of theskin; second degree, those which show vesication of the skin; and thirddegree, those which produce necrosis through the entire skin.

Wound dressings suitable for use in treating burns, bedsores, etc. aredisclosed in U.S. Pat. Nos. 4,300,575; 3,903,882; 3,949,071 and CanadianPatent No. 1,212,879. Moreover, it has been found that the timelyapplication of the compositions of the present invention substantiallyreduces or eliminates the occurrence of scarring as a result of suchburns, bedsores, etc.

Prior to the present invention, while many dressings and topical agentshave been available for use in the treatment of burns, bedsores, etc.,they are as a rule all expensive and in many cases totally useless.

The present invention is concerned with inexpensive, highly effectivecompositions for the treatment of burns, bedsores and other skinafflictions which comprises a mixture of an aqueous solution of calciumhydroxide and a fixed drying oil, such as linseed oil.

Calcium hydroxide topical solutions commonly referred to as lime waterare described in The Official Monographs at page 109 of the 1980 Editionof the U.S. Pharmacopia National Formulary.

The solutions generally contain not less than 0.14 gm. of Ca(OH)₂ per100 cc. of water at 25° C. and are prepared by adding 3 grams of calciumhydroxide to purified water with vigorous mixing for at least one hour.The excess calcium hydroxide is allowed to settle. The film of calciumcarbonate forming on the surface is skimmed and only the clearsupernatant liquid is decanted and utilized in the formulations of thepresent invention. Moreover, the undissolved portion or slaked lime isnot suitable for preparing additional quantities of calcium hydroxidesolution.

The calcium hydroxide content of the solutions is directly related tothe temperature of the water during processing as well as thetemperature at which the finished solution is stored. The calciumhydroxide content at 15° C. is about 0.17 gm. per 100 cc. and less athigher temperatures. The official concentration is determined at 25° C.

The fixed drying oils useful in the preparation of the compositions ofthe present invention are the oils obtained from seeds such as flax seedoil, commonly known as linseed oil, walnut seed oil, poppy seed oil,hemp seed oil and sunflower seed oil. The pharmaceutical grade of rawlinseed oil, the preferred fixed drying oil employed in the presentinvention is readily available on a commercial basis.

The ratio of aqueous calcium hydroxide solution to fixed drying oilemployed in the present invention can be varied over wide limits,however, a mixture of equal parts aqueous calcium hydroxide and fixeddrying oil is preferred.

A preferred composition and method for carrying out the presentinvention is illustrated by the following example:

EXAMPLE

Sixteen ounces of water are combined with six ounces of lime, which whenfreshly ignited to constant weight, contains not less 95.0 percent ofCaO, and the mixture allowed to stand for twelve hours after which afilm composed primarily of calcium carbonate is skimmed from the surfaceof the mixture and the upper aqueous phase of the mixture is decantedand filtered. Four ounces of raw linseed oil is slowly added to fourounces of the filtrate and the mixture vigorously stirred until themixture thickens which is on the order of about three minutes.

The thickened mixture is applied directly to the burn, bedsore orotherwise affected skin area and the area maintained in a moistenedcondition.

While the preferred mode of application is to daube the mixture directlyonto the affected skin area, the compositions of the present inventionmay also be sprayed or combined with suitable pharmaceutical carriers orbases for application.

Moreover, while best results are achieved using freshly made upcompositions, the compositions may be stored in well filled, tightcontainers at temperatures not exceeding 25° C.

Numerous modifications and variations of the present invention arepossible in light of the above teachings and therefore within the scopeof the appended claims, and the invention may be practiced otherwisethan as particularly described.

We claim:
 1. A composition suitable for the topical treatment of burnsand sores consisting essentially of about equal parts of an aqueoussolution of calcium hydroxide containing not less than about 0.14 gramsof Ca(OH)₂ per 100 cc. of water at 25° C. and raw linseed oil.
 2. Amethod of treating burns and sores on the skin of warm-blooded animalsin need of such treatment which comprises applying to said burns andsores a mixture consisting essentially of from about equal parts of anaqueous solution of calcium hydroxide containing not less than about0.14 grams of Ca(OH)₂ per 100 cc. of water at 25° C. and a fixed dryingoil.
 3. A method as claimed in claim 2 wherein said fixed drying oil isselected from the group consisting of walnut oil, poppy oil, hemp oil,sunflower oil and linseed oil.
 4. A method as claimed in claim 2 whereinsaid fixed drying oil is raw linseed oil.